Journal articles on the topic 'Cross-national construct equivalence'

As a research method, focus groups have methodological advantages for understanding the views and behavior of group members or for understanding the social system as a whole, since it covers the interaction between people, groups, and the interpersonal environment quite well that widely recognized in the social sciences. These advantages are introduced in the context of mixed-methods, including conducting a survey together with focus groups as a pretest questionnaire in a comparative perspective in cross-national and cross-culture research. Focus groups provide to reach construct equivalence and elaborate an appropriate context-oriented language for questionnaire questions. Using the focus groups in this way can be an effective approach to overcoming the initial limited ability of surveys to valid measure more complex socially constructed concepts, the meaning of which can vary significantly from one group to another, especially from a comparative perspective in cross-national and cross-culture research. Using focus groups, data is collected in a more natural way, that is, more close to the real world, while the generalization is ensured by a detailed description of specific conditions, participants, and research environment. In addition, the discussion group is a miniature thinking society, and unlike dyadic interviews or surveys, focus group discussions give participants the opportunity to express their opinions, discuss their views and opinions with other participants, listen to other peoples opinions, disagree or to develop thoughts by reasoning out loud - this is similar to what happens in real life. This increased awareness about the described advantages of the approach for cross-cultural and cross-national comparative research likely contributes to its more active employ.

PurposeThis paper empirically addresses the question of whether the meaning of ethical leadership is constant across cultures. Drawing on the implicit leadership theory (ILT), we examine whether people in Australia and Pakistan respond to perceived ethical leadership in a similar or different manner. By comparing employees' interpretation of the key attributes associated with ethical leadership, we advance construct-specific knowledge in cross-national contexts.Design/methodology/approachSince meaningful cross-country comparisons of a research construct require an equivalent measurement of it, we examine the issue of cross-cultural measurement invariance of ethical leadership. Specifically, this study explores the configural, metric and scalar invariance of ethical leadership by obtaining data from matched international samples.FindingsThe findings broadly support cross-cultural generalisability of the construct's meaning and cross-cultural transferability of the ethical leadership scale (ELS). They suggest that measures of ethical leadership constructs should be used in different cultures with caution because significant differences may exist at the item level.Originality/valueThis study provides cross-cultural endorsement to the construal of ethical leadership by presenting evidence that supports convergence in the construct's meaning across Eastern and Western cultures. The study has enhanced the construct validity of ethical leadership through the use of the refined multiple-sample analytical approach. Previous studies have assumed that measures of ethical leadership are invariant across various contexts. However, this is the first study to employ a robust methodological technique (metric and path invariance) that demonstrates the significant difference between each item and path and generalises the validity of ethical leadership construct and its measures by using international samples.

Researchers in comparative research are increasingly relying on individual level data to test theories involving unobservable constructs like attitudes and preferences. Estimation is carried out using large-scale cross-national survey data providing responses from individuals living in widely varying contexts. This strategy rests on the assumption of equivalence, that is, no systematic distortion in response behavior of individuals from different countries exists. However, this assumption is frequently violated with rather grave consequences for comparability and interpretation. I present a multilevel mixture ordinal item response model with item bias effects that is able to establish equivalence. It corrects for systematic measurement error induced by unobserved country heterogeneity, and it allows for the simultaneous estimation of structural parameters of interest.

Purpose – In light of increasing globalization of workforces, the purpose of this paper is to explore the moderating effect of country on the relationship between job resources and employee engagement. Design/methodology/approach – Questionnaire responses from 19,260 employees of a large multinational financial services corporation in Mexico, the Netherlands, and the USA are analyzed using regression analyses and a study of effect sizes. Findings – The results show that certain job resources (financial rewards, team climate, participation in decision making) positively influence engagement in all three countries. However, the study also shows distinctions between the strength of relationships between these job resources and engagement per country which are explained through cross-cultural theorizing. Research limitations/implications – National-level variations in relationships between job resources and employee engagement are evidenced, and these can be explained to a considerable extent by applying a cross-cultural theoretical lens. Practical implications – The study highlights the importance for firms to be aware of and learn from the equivalence of constructs and their relationships across countries: although similar relationships were observed across the three countries studied here, the differences may be sufficient to require alternate approaches to appropriate job resources to engender engagement. Originality/value – Although there has been considerable empirical investigation into the relationship between job resources and engagement, little has focussed on different national settings simultaneously.

Abstract. The short(s)-EMBU (Swedish acronym for Egna Minnen Beträffande Uppfostran [My memories of upbringing]) consists of 23 items, is based on the early 81-item EMBU, and was developed out of the necessity of having a brief measure of perceived parental rearing practices when the clinical and/or research context does not adequately permit application of time-consuming test batteries. The s-EMBU comprises three subscales: Rejection, Emotional Warmth, and (Over)Protection. The factorial and/or construct validity and reliability of the s-EMBU were examined in samples comprising a total of 1950 students from Australia, Spain, and Venezuela. The data were presented for the three national groups separately. Findings confirmed the cross-national validity of the factorial structure underlying the s-EMBU. Rejection by fathers and mothers was consistently associated with high trait-neuroticism and low self-esteem in recipients of both sexes in each nation, as was high parental emotional warmth with high femininity (humility). The findings on factorial validity are in keeping with previous ones obtained in East Germany, Greece, Guatemala, Hungary, Italy, and Sweden. The s-EMBU is again recommended for use in several different countries as a reliable, functional equivalent to the original 81-item EMBU.

The Pool Critical Assembly Pressure Vessel (PCA) benchmark is a well known benchmark in the reactor shielding community which is described in the Shielding Integral Benchmark Archive and Database (SINBAD). It is based on the experiments performed at the PCA facility in the Oak Ridge National Laboratory (ORNL) and it can be used for the qualification of the pressure vessel fluence calculational methodology. The measured quantities to be compared against the calculated values are the equivalent fission fluxes at several experimental access tubes (A1 to A8) in front, behind, and inside the pressure-vessel wall simulator. This benchmark is particularly suitable to test the capabilities of the shielding calculational methodology and cross-section libraries to predict invessel flux gradients because only a few approximations are necessary in the overall analysis. This benchmark was analyzed using a modern hybrid stochastic-deterministic shielding methodology with ADVANTG3.0.1 and MCNP6.1.1b codes. ADVANTG3.0.1 is an automated tool for generating variance reduction (VR) parameters for Monte Carlo (MC) calculations with MCNP5v1.60 code (and higher versions). It is based on the multigroup, discrete ordinates solver Denovo, used for approximating the forward-adjoint transport fluxes to construct VR parameters for the final MC simulation. The VR parameters in form of the weight windows and the source biasing cards can be directly used with unmodified MCNP input. The underlining CADIS methodology in Denovo code was initially developed for biasing local MC results, such as point detector or a limited region detector. The FW-CADIS extension was developed for biasing MC results globally over a mesh tallies or multiple point/region detectors. Both CADIS and FW-CADIS are based on the concept of the neutron importance function, which is a solution of the adjoint Boltzmann transport equation. The equivalent fission fluxes calculated with MCNP are based on several highenergy threshold reactions from international dosimetry libraries IRDF-2002 and IRDFF-2014, distributed by the IAEA Nuclear Data Section. The obtained results show a good agreement with referenced PCA measurements. Visualization of the deterministic solution in 3D was done using the VisIt code from the Lawrence Livermore National Laboratory (LLNL).

Abstract Objective To analyze the completeness, computability, and accuracy of specifications for five National Quality Forum-specified (NQF) eMeasures spanning ambulatory, post-discharge, and emergency care within a comprehensive, integrated electronic health record (EHR) environment. Materials and methods To evaluate completeness, we assessed eMeasure logic, data elements, and value sets. To evaluate computability, we assessed the translation of eMeasure algorithms to programmable logic constructs and the availability of EHR data elements to implement specified data criteria, using a de-identified clinical data set from Kaiser Permanente Northwest. To assess accuracy, we compared eMeasure results with those obtained independently by existing audited chart abstraction methods used for external and internal reporting. Results One measure specification was incomplete; missing applicable LOINC codes rendered it non-computable. For three of four computable measures, data availability issues occurred; the literal specification guidance for a data element differed from the physical implementation of the data element in the EHR. In two cases, cross-referencing specified data elements to EHR equivalents allowed variably accurate measure computation. Substantial data availability issues occurred for one of the four computable measures, producing highly inaccurate results. Discussion Existing clinical workflows, documentation, and coding in the EHR were significant barriers to implementing eMeasures as specified. Implementation requires redesigning business or clinical practices and, for one measure, systemic EHR modifications, including clinical text search capabilities. Conclusions Five NQF eMeasures fell short of being machine-consumable specifications. Both clinical domain and technological expertise are required to implement manually intensive steps from data mapping to text mining to EHR-specific eMeasure implementation.

Background Care home staff have a critical bearing on quality. The staff employed, the training they receive and how well they identify and manage residents’ needs are likely to influence outcomes. The Care Act 2014 (Great Britain. The Care Act 2014. London: The Stationery Office; 2014) requires services to improve ‘well-being’, but many residents cannot self-report and are at risk of exclusion from giving their views. The Adult Social Care Outcomes Toolkit enables social care-related quality of life to be measured using a mixed-methods approach. There is currently no equivalent way of measuring aspects of residents’ health-related quality of life. We developed new tools for measuring pain, anxiety and depression using a mixed-methods approach. We also explored the relationship between care home quality, residents’ outcomes, and the skill mix and employment conditions of the workforce who support them. Objectives The objectives were to develop and test measures of pain, anxiety and depression for residents unable to self-report; to assess the extent to which regulator quality ratings reflect residents’ care-related quality of life; and to assess the relationship between aspects of the staffing of care homes and the quality of care homes. Design This was a mixed-methods study. Setting The setting was care homes for older adults in England. Participants Care home residents participated. Results Three measures of pain, anxiety and low mood were developed and tested, using a mixed-methods approach, with 182 care home residents in 20 care homes (nursing and residential). Psychometric testing found that the measures had good construct validity. The mixed-methods approach was both feasible and necessary with this population, as the majority of residents could not self-report. Using a combined data set (n = 475 residents in 54 homes) from this study and the Measuring Outcomes in Care Homes study (Towers AM, Palmer S, Smith N, Collins G, Allan S. A cross-sectional study exploring the relationship between regulator quality ratings and care home residents’ quality of life in England. Health Qual Life Outcomes 2019;17:22) we found a significant positive association between residents’ social care-related quality of life and regulator (i.e. Care Quality Commission) quality ratings. Multivariate regression revealed that homes rated ‘good/outstanding’ are associated with a 12% improvement in mean current social care-related quality of life among residents who have higher levels of dependency. Secondary data analysis of a large, national sample of care homes over time assessed the impact of staffing and employment conditions on Care Quality Commission quality ratings. Higher wages and a higher prevalence of training in both dementia and dignity-/person-centred care were positively associated with care quality, whereas high staff turnover and job vacancy rates had a significant negative association. A 10% increase in the average care worker wage increased the likelihood of a ‘good/outstanding’ rating by 7%. Limitations No care homes rated as inadequate were recruited to the study. Conclusions The most dependent residents gain the most from homes rated ‘good/outstanding’. However, measuring the needs and outcomes of these residents is challenging, as many cannot self-report. A mixed-methods approach can reduce methodological exclusion and an over-reliance on proxies. Improving working conditions and reducing staff turnover may be associated with better outcomes for residents. Future work Further work is required to explore the relationship between pain, anxiety and low mood and other indicators of care homes quality and to examine the relationship between wages, training and social care outcomes. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 19. See the NIHR Journals Library website for further project information.

OBJECTIVES/SPECIFIC AIMS: Research overview: Providing patient-centered care is increasingly a top priority in the U.S. healthcare system.1,2 Hospitals are required to publicly report patient-centered assessments, including results from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction surveys.3 Furthermore, clinician and hospital reimbursements are partially determined by performance on patient satisfaction measures.3 Consequently, hospitals and clinicians may be incentivized to improve patient satisfaction scores over other important outcomes.4 Paradoxically then, the pursuit of patient-centered care may lead clinicians to fulfill patient requests for unnecessary and potentially harmful treatments.5 Opioid prescribing during hospitalizations may be particularly affected by clinicians’ seeking to optimize patient satisfaction scores.6,7 Satisfaction with pain care is an important predictor of overall patient satisfaction in the HCAHPS surveys,8,9 and clinicians report increased pressure to fulfill patient requests for immediate pain-relief.10,11 Therefore, clinicians may prescribe opioids to avoid receiving lower patient satisfaction scores.12,13 Furthermore, clinicians lack clear guidance on opioid prescribing for some populations, including non-surgical inpatients, who represent almost half of all hospitalizations.14 To reduce clinicians’ incentive to prescribe opioids as a means of achieving patient satisfaction, the Center for Medicare and Medicaid Services (CMS) temporarily removed questions related to patient satisfaction with pain care from the clinician and hospital reimbursement formulas beginning in 2018.15 Importantly, prior research16-20 has not rigorously tested the hypothesis implied by the CMS policy change: that certain opioid prescribing practices in inpatient pain care are associated with higher patient satisfaction. Objectives: The purpose of this study was to evaluate the association between the receipt/dose of opioids during non-surgical hospitalizations and patient satisfaction measured by the HCAHPS survey. METHODS/STUDY POPULATION: Methods/Study Population: We conducted a pooled cross-sectional study of adults (18 and older) with non-surgical hospitalizations within the 11-hospital healthcare system in a Midwestern state from 2011-2016. Data were extracted from electronic health records and linked to HCAHPS patient satisfaction surveys. We estimated the propensity score for receipt of any opioids during hospitalization and separately the receipt of high dose opioids (≥100 morphine milligram equivalent [MME]) based on patient, encounter, and facility characteristics for all hospitalizations with complete data. We used nearest neighbor matching to construct two matched samples to minimize selection bias and confounding by indication. We used a standardized difference threshold of < 0.1 as an indication of the balance between matched groups. Outcomes were compared with a test on the equality of proportions using large-sample statistics. All analysis was performed in STATA 14.0 analytical software. Main outcomes: We analyzed four dependent variables. Two pain-specific patient satisfaction variables were derived from the responses to the following survey questions: 1) “During this hospital stay, how often your pain was well controlled? (pain control)” and 2) “During this hospital stay, how often did the hospital staff do everything they could to help you with your pain? (pain help)”, with 4-point Likert scale responses ranging from “Never” to “Always.” We also used two global satisfaction measures derived from the responses to the following survey questions: 1) “Using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible, what number would you use to rate this hospital during your stay (overall patient satisfaction)?” and 2) “Would you recommend this hospital to your friends and family (willingness to recommend a hospital)? (4-point scale of “Definitely Yes” to “Definitely No”). Because the responses are not normally distributed, and the response options are truncated, we dichotomized each of these questions following previously published approaches8 and CMS methodology3 (e.g. “always” vs. all other responses or “9 or 10 rating” vs. all others). RESULTS/ANTICIPATED RESULTS: Results: Among 17,691 patients who reported that they needed pain medications during hospitalization in their HCAHPS survey, 43.7% (n=7,735) received opioids. Among the matched sample (n=8,848), 55% were female, 90% were white, 9% were black, 74% were emergency admissions, 29% had a circulatory diagnosis, 92% were discharged home, and the average pain score ranged from 0.2 to 7.1 during the hospital stay. Compared to matched patients hospitalized but did not receiving opioids, those who received opioids did not significantly differ in their rating of pain help (75% of patients without opioids rated that they always received help for their pain versus 75% of patients with opioids; p=.78), pain control (55% of patients without opioids reported that their pain was well controlled versus 54% on opioids; p=.93), willingness to recommend the hospital (69% of patients without opioids reported that they would definitely recommend a hospital versus 71% with opioids; p=.16) and overall rating of their care (47% of patients without opioids rated their hospitalization as 10 versus 46% on opioids; p=.22). DISCUSSION/SIGNIFICANCE OF IMPACT: Discussion: We found no evidence that receipt of opioids is associated with patient satisfaction, including at doses. To our knowledge, this is the first study that used propensity score matching to examine the association between inpatient opioid prescribing practices and patient satisfaction. Furthermore, our sample is unique in the inclusion of patients hospitalized for non-surgical indicators over a five year period in the multi-hospital healthcare system in a Midwestern state. Our findings add to the existing literature which has shown contradictory associations between opioid prescribing and patient satisfaction.16-22 Specifically, few studies that looked at surgical inpatients showed a lack of association between patient satisfaction16,18 and opioid prescribing, whereas others showed that receipt of opioids was associated with lower patient satisfaction.17-20 Our findings may imply that satisfaction with pain care may be achieved without administering opioids to non-surgical inpatients. Alternatively, satisfaction with pain care may not be influenced by opioid prescribing for non-surgical inpatients. Future research should further examine the association between opioid prescribing and patient satisfaction among non-surgical inpatients on a national scale to get a better understanding of the relationship between certain pain care practices and patient satisfaction.

This research investigated the psychometric properties of the Prosociality Scale and its cross-cultural validation and generalizability across five different western and non-western countries (China, Chile, Italy, Spain, and the United States). The scale was designed to measure individual differences in a global tendency to behave in prosocial ways during late adolescence and adulthood. Study 1 was designed to identify the best factorial structure of the Prosociality Scale and Study 2 tested the model’s equivalence across five countries (N = 1,630 young adults coming from China, Chile, Italy, Spain and the United States; general Mage = 21.34; SD = 3.34). Findings supported a bifactor model in which prosocial responding was characterized by a general latent factor (i.e., prosociality) and two other specific factors (prosocial actions and prosocial feelings). New evidence of construct validity of the Prosociality Scale was provided.

Background Physiotherapy in Palliative Care (PC) is effective in the management of a series of respiratory, circulatory and motor symptoms, and often has a positive impact on the patient's mood. The Edmonton Functional Assessment Tool (EFAT) is the only existing validated tool specifically designed for functional assessment in PC, and its use has been recommended in clinical practice. To date, no Italian version of the tool has been validated. The aim of this study was to translate, cross-culturally adapt, and evaluate the psychometric properties of the Italian version of the EFAT2. Method After receiving formal permission from the author, Beaton guidelines for cross-cultural adaptation were followed, namely: (1) forward translation; (2) a multidisciplinary focus group (including 4 physiotherapists, 1 physician, 3 nurses, 1 occupational therapist, 1 psychologist) to assess semantic, idiomatic, experiential, and conceptual equivalence; (3) backward translation. The Content Validity Index (CVI) was used to assess content validity of the tool. Construct and concurrent validity were also evaluated. To evaluate the reliability of the EFAT2-I, reliability was measured using Cronbach alfa, item-total correlation, and Cohen's Kappa. Results 119 patients admitted to a Palliative Care Unit (Italy) agreed to participate in the study. The EFAT2-I mean score was 11.3, ranging from 0 to 30. Very good CVI scores were achieved, both in terms of single item validity (I-CVI) and of whole scale validity (S-CVI). Positive results were obtained from construct, concurrent validity assessment and measures of reliability. Discussion The EFAT2-I showed good psychometric properties and can be used as a rehabilitation assessment tool in palliative care settings. The validation of the Italian version will allow comparison of different centres and palliative care facilities on national and international levels.

Scholars study representative international surveys to understand cross-cultural differences in mentality patterns, which are measured via complex multi-item constructs. Methodologists in this field insist with increasing vigor that detecting “non-invariance” in how a construct’s items associate with each other in different national samples is an infallible sign of encultured in-equivalences in how respondents understand the items. Questioning this claim, we demonstrate that a main source of non-invariance is the arithmetic of closed-ended scales in the presence of sample mean disparity. Since arithmetic principles are culture-unspecific, the non-invariance that these principles enforce in statistical terms is inconclusive of encultured in-equivalences in semantic terms. Because of this inconclusiveness, our evidence reveals furthermore that non-invariance is inconsequential for the cross-cultural functioning of multi-item constructs as concerns their nomological linkages to other variables of interest. We discuss the implications of these insights for measurement validation in cross-cultural settings with large sample mean disparity.

A cross-national study was conducted on a new test anxiety measure, the Test Anxiety Measure for College Students-Short Form (TAMC-SF) in a sample of 1,023 Singapore and U.S. students, aged 18-26. The TAMC-SF consists of one facilitating anxiety scale and five test anxiety (Worry, Cognitive Interference, Social Concerns, Physiological Hyperarousal, and Task Irrelevant Behaviors) scales. The measure was administered to the sample of higher education students online. The results of single-group confirmatory factor analyses found support for the TAMC-SF six-factor model for Singapore students, U.S. students, male students, and female students. In addition, the results of multi-group, mean and covariance structure analysis found support for the construct equivalency of the TAMC-SF scores across country and gender. Latent mean factor analyses followed and the results of these analyses indicated Singapore students had significantly higher levels of social concerns and significantly lower levels of cognitive interference and worry than U.S. students. The findings also indicated females had significantly higher levels of test anxiety than males on all five TAMC-SF test anxiety scales. Evidence supporting the construct validity of the TAMC-SF scores with the scores of math anxiety, social phobia, and self-critical perfectionism was also reported. Implications of the study’s findings for researchers and clinicians are discussed.

General belief in the justice, in well-ordered and balanced social relations, the system where people get what they deserve is described in the concept of M. Lerner as “belief in the just world” (BJW). BJW helps to justify existing inequalities, to cope with unjust life situations, to keep optimistic view, but can also be a barrier for questioning and changing of unfair social relations. The research based on data of 9th round of Russian social survey (RSS) and European social survey (ESS) conducted in 30 countries revealed the prevalence of rational-skeptical view of Europeans on the chances of general justice. The average level of BJM appeared to be relatively low in Russia and in most other countries included in the analysis. To confirm the methodological rigor of these conclusions, the evaluation of statistical cross-national equivalency of BJM scale was conducted. The empirical validity of the BJW scale in Russia was assessed using cognitive interviews on randomly selected follow-up sample among RSS respondents. It showed the interpretative and motivational multidimensionality of the concept, but also the consistency of empirical semantic space of the concept to theoretical construct and general validity of the scale. Factors influencing the formation of BJW have two-fold structure. The impact of value-cultural factor leads to the similarity of views on BJW in Russia and in Europe on aggregate level. Personal situation and socio-demographic factors plays on individual level have differential impact. BJW as general worldview attitude has strong impact on framing particular socio-political attitudes and evaluations. High level of BJW is related to loyalty toward existing political system, trust to governing institutions and positive evaluation of incumbent’s performance which is consistent with findings from previous research. In opposite, the hypothesis on the impact of BJW on the support of conservative ideology and anti-liberal social attitudes was not confirmed.

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) has requested the Norwegian Food Safety Authority (NFSA) to give final opinions on all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC within the Authority’s sectoral responsibility. The Norwegian Food Safety Authority has therefore, by letter dated 13 February 2013 (ref. 2012/150202), requested the Norwegian Scientific Committee for Food Safety (VKM) to carry out scientific risk assessments of 39 GMOs and products containing or consisting of GMOs that are authorized in the European Union. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. MON810 notification C/F/95/12-02 is approved under Directive 90/220/EEC for cultivation, seed production, import and processing into feeding stuffs and industrial purposes since 22 April 1998 (Commission Decision 98/294/EC). In December 1997, food and food ingredients derived from the progeny of maize line MON810 were notified under Article 5 of Regulation (EC) No 258/97 on novel foods and novel food ingredients. In addition, existing food and feed products containing, consisting of or produced from MON810 were notified according to Articles 8 and 20 of Regulation (EC) No 1829/2003 and were placed in the Community Register in 2005. Three applications for renewal of the authorisation for continued marketing of (1) existing food and food ingredients produced from MON810; (2) feed consisting of and/or containing maize MON810, and MON810 for feed use (including cultivation); and (3) food and feed additives, and feed materials produced from maize MON810 within the framework of Regulation (EC) No 1829/2003 were submitted in 2007. Maize MON810 has previously been assessed by the VKM GMO Panel commissioned by the Norwegian Environment Agency in connection with the national finalisation of the procedure of the notification C/F/95/12/02 (VKM 2007a,b). In addition, MON810 has been evaluated by the VKM GMO Panel as a component of several stacked GM maize events (VKM 2005a,b,c, VKM 2007c, VKM 2008, VKM 2009, VKM 2012a). Due to the publication of new scientific literature and updated guidance for food/feed and environmental risk assessment of genetically modified plants, the VKM GMO Panel has decided to deliver an updated risk assessment of MON810. The updated risk assessment of the maize MON810 is based on information provided by the applicant in the notification C/F/95/12/02 and application EFSA/GMO/RX/MON810, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MON810 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The VKM GMO panel has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), and the selection of comparators for the risk assessment of GM plants (EFSA 2011b). The scientific risk assessment of maize MON810 includes molecular characterisation of the transformation process, vector construction, expression, inheritance and stability of the transgene construct, comparative assessment of agronomic and phenotypic characteristics, nutritional assessments, toxicology and allergenicity, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms and effects on biogeochemical processes. It is emphasized that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms. The genetically modified maize MON810 was developed to provide protection against certain lepidopteran target pests, including European corn borer (Ostrinia nubilalis) and species belonging to the genus Sesamia. Protection is achieved through expression in the plant of the insecticidal Cry protein, Cry1Ab, derived from Bacillus thuringiensis ssp. kurstaki, a common soil bacterium. Molecular Characterisation: Appropriate analysis of the integration site including flanking sequences and bioinformatics analyses have been performed to analyse the construct integrated in the GM plant. Updated bioinformatics analyses revealed that one ORF shared sequence similarity to a putative HECT-ubiquitin ligase protein. The VKM GMO Panel found no safety implications from the interruption of this gene sequence. Analyses of leaf, grains, whole plant tissue and pollen from the maize MON810 demonstrated that the Cry1Ab protein is expressed at very low levels in all tissues tested and constitute less than 0.001% of the fresh weight in each tissue. The cry1Ab gene is the only transgene expressed in line MON810 and is expressed the highest in leaves. The stability of the genetic modification has been demonstrated over several generations. Event MON810 and the physical, chemical and functional characteristics of the proteins have previously been evaluated by The VKM Panel on Genetically Modified Organisms, and considered satisfactory (VKM 2007a,b). Comparative Assessment: Compositional assessments were performed using the principles and analytes outlined in the OECD consensus document for maize composition (OECD 2002). For maize MON810 grain and forage, VKM previously concluded, based on data from risk assessments and field trials as presented in notification MON810 (C/F/95/12/02) and application NK603 x MON810 (EFA/GMO/UK/2004/1), MON 863 x MON810 (EFSA/GMO/DE/2004/03), MON863xMON810x NK603 (EFSA/GMO/BE/2004/07) and MON 88017 x MON810 (EFSA/GMO/ CZ/2006/33), that maize MON810 is compositionally similar to the non-GM counterparts and conventional maize varieties, except for the new trait (VKM 2005a,b,c, 2007a,b,c). Comparative analyses of data from field trials located at representative sites and environments in the USA and Europe indicate that maize MON810 is agronomically and phenotypically equivalent to the conventional counterpart and commercially available reference varieties, with the exception of the lepidopteran-protection trait, conferred by the expression of the Cry1Ab protein. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of MON810 compared to conventional maize. Evaluations of ecological interactions between maize MON810 and the biotic and abiotic environment indicate no unintended effects of the introduced trait on agronomic and phenotypic characteristics. Food and Feed Safety Assessment: Based on current knowledge, there is no reason to assume that the characteristics of processed products derived from maize MON810 would be different from processed products derived from nonGM maize. The compositional and nutritional equivalence of MON810 to conventional non-GM maize varieties is supported by several animal studies. Acute oral toxicity tests have not indicated any toxicity related to the Cry1Ab protein from Bacillus thuringiensis. Cry1Ab is readily degraded in simulated gastric fluids and no adverse health effects have been reported related to maize MON810 from whole food feeding studies performed on rats, broilers, pigs or dairy cows. Some studies on Atlantic salmon have however indicated possible immunological reactions related to MON810 in fish feed. Bioinformatics analyses show no resemblance of the Cry1Ab protein to known toxins or allergens. Cry1Ab has not been shown to cause IgE mediated allergic reactions and is considered a non-allergenic by EFSA. Some studies have however indicated a potential role of Cryproteins as adjuvants in allergic reactions (VKM 2012b). Environmental Risk: There are no reports of the target lepidopteran species attaining pest status on maize in Norway. Since there are no Bt-based insecticides approved for use in Norway, and lepidopteran pests have not been registered in maize, issues related to resistance evolution in target pests are not relevant at present for Norwegian agriculture. Published scientific studies show no or negligible adverse effects of Cry1Ab protein on non-target arthropods that live on or in the vicinity of maize plants. Cultivation of maize MON810 is not considered to represent a threat to the prevalence of red-listed species in Norway. Few studies have been published examining potential effects of Cry1Ab toxin on ecosystems in soil, mineralization, nutrient turnover and soil communities. Some field studies have indicated that root exudates and decaying plant material containing Cry proteins may affect population size and activity of rhizosphere organisms (soil protozoa and microorganisms). Most studies conclude that effects on soil microorganisms and microbial communities are transient and minor compared to effects caused by agronomic and environmental factors. However, data are only available from short term experiments and predictions of potential long term effects are difficult to deduce. Few studies have assessed the impact of Cry proteins on non-target aquatic arthropods and the fate of these proteins in senescent and decaying maize detritus in aquatic environments. However, exposure of non-target organisms to Cry proteins in aquatic ecosystems is likely to be very low, and potential exposure of Bt toxins to non-target organisms in aquatic ecosystems in Norway is considered to be negligible. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation with which maize can hybridise and form backcross progeny. Vertical gene transfer in maize therefore depends on cross-pollination with other conventional or organic maize varieties. In addition, unintended admixture of genetically modified material in seeds represents a possible way for gene flow between different crop cultivations. The risk of pollen flow from maize volunteers is negligible under Norwegian growing conditions. In addition to the data presented by the applicant, the VKM GMO Panel is not aware of any scientific report of increased establishment and spread of maize MON810 and any change in survival (including over-wintering), persistence and invasiveness capacity. Because the general characteristics of maize MON810 are unchanged, insect resistance are not likely to provide a selective advantage outside cultivation in Norway. Since MON810 has no altered agronomic and phenotypic characteristics, except for the specific target pest resistance, the VKM GMO Panel is of the opinion that the likelihood of unintended environmental effects due to the establishment and survival of maize MON810 will be no different to that of conventional maize varieties in Norway. Overall Conclusion: The VKM GMO Panel has not identified toxic or altered nutritional properties of maize MON810 or its processed products compared to conventional maize. Based on current knowledge, it is also unlikely that the Cry1Ab protein will increase the allergenic potential of food and feed derived from maize MON810 compared to conventional maize varieties. The VKM GMO Panel likewise concludes that cultivation of maize MON810 is unlikely to have any adverse effect on the environment and agriculture in Norway.

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) and the Norwegian Food Safety Authority (NFSA) to conduct final food/feed and environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency and NFSA requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The herbicide-tolerant genetically modified maize GA21 from Syngenta Seeds (Unique Identifier MON-ØØØ21-9) is authorised for the import and placing on the market as food or feed in the EU pursuant to Regulation (EC) 1829/2003 by the Commission Decision 2008/280/EC. An application for granting consent to all uses of GA21 maize including the cultivation was submitted by Syngenta in accordance with articles 5 and 17 of the Regulation (EC) No. 1829/2003 on June 30 2008. Maize GA21 has previously been assessed as food and feed by the VKM GMO Panel commissioned by the Norwegian Food Safety Authority in connection with the national finalisation of the procedure of the notification C/ES/98/01 in 2005 (VKM 2005a). VKM also participated in the 90 days public consultation of the application for placing on the market of maize GA21 for food and feed uses, import, processing and cultivation (EFSA/GMO/UK/2008/60) in 2009, and submitted a preliminary opinion in April 2010 (VKM 2010). GA21 has also been evaluated by the VKM GMO Panel as a component of several stacked GM maize events under and Regulation (EC) 1829/2003 (VKM 2008, VKM 2009a,b,c,d, VKM 2012a,b, VKM 2013a,b,c). Due to the publication of new scientific literature and updated guidelines for risk assessment of genetically modified plants, the VKM GMO Panel has decided to deliver an updated food/feed and environmental risk assessment of GA21. The updated food/feed and environmental risk assessment of the maize GA21 is based on information provided by the applicant in the applications EFSA/GMO/UK/2005/19, EFSA/GMO/UK/2008/60 and EFSA/GMO/RX/GA21 and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated GA21 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2011a), the environmental risk assessment of GM plants (EFSA 2010), selection of comparators for the risk assessment of GM plants (EFSA 2011b) and for the post-market environmental monitoring of GM plants (EFSA 2011c). The scientific risk assessment of maize GA21 include molecular characterisation of the inserted DNA and expression of novel proteins, comparative assessment of agronomic and phenotypic characteristics, nutritional assessments, toxicology and allergenicity, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms and effects on biogeochemical processes. It is emphasized that the VKM mandate does not include assessments of contribution to sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act. These considerations are therefore not part of the risk assessment provided by the VKM Panel on Genetically Modified Organisms. Maize GA21 expresses a modified version of 5-enolpyruvylshikimate-3-phosphate synthase (mEPSPS), which is derived from maize EPSPS, and renders maize GA21 tolerant to the herbicidal active substance glyphosate. Molecular Characterization: The molecular characterisation data indicate that several copies of the GA21 construct are integrated at a single locus in the DNA, and that they are inherited as a dominant, single locus trait. Appropriate analyses of the integration site, inserted DNA sequence, flanking regions, and bioinformatics have been performed. The VKM GMO Panel considers the molecular characterisation of maize GA21 as adequate. Comparative Assessment: Comparative analyses of maize event GA21 to its conventional counterpart) have been performed during multiple field trials located at representative sites and environments in North America (1997, 2004, and 2005), Europe (1996, 1997, and 2006) and Brazil (2003). With the exception of small intermittent variations, no biologically significant differences were found between maize GA21 and controls. Based on the assessment of available data, the VKM GMO Panel concludes that maize GA21 is compositionally, agronomically and phenotypically equivalent to its conventional counterpart, except for the mEPSPS protein, and that its composition fell within the range observed among nonGM varieties. Food and Feed Risk Assessment: Whole food feeding studies in rats, broilers and cattles have not indicated any adverse health effects of maize GA21. These studies also indicate that maize GA21 is nutritionally equivalent to conventional maize. The mEPSPS protein does not show sequence resemblance to other known toxins or IgE allergens, nor has mEPSPS been reported to cause IgE mediated allergic reactions. Based on current knowledge, the VKM GMO Panel concludes that maize GA21 is nutritionally equivalent to conventional maize varieties. It is unlikely that the mESPSPS protein will introduce a toxic or allergenic potential in food or feed based on maize GA21 compared to conventional maize. Environmental Risk Assessment: The scope of the application EFSA/GMO/UK/2005/19 includes import and processing of maize GA21 for food and feed uses. Considering the intended uses of maize GA21, excluding cultivation, the environmental risk assessment is concerned with accidental release into the environment of viable grains during transportation and processing, and indirect exposure, mainly through manure and faeces from animals fed grains from maize GA21. Maize GA21 has no altered survival, multiplication or dissemination characteristics, and there are no indications of an increased likelihood of spread and establishment of feral maize plants in the case of accidental release into the environment of seeds from maize GA21. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation. The VKM GMO Panel considers the risk of gene flow from occasional feral GM maize plants to conventional maize varieties to be negligible in Norway. Considering the intended use as food and feed, interactions with the biotic and abiotic environment are not considered by the GMO Panel to be an issue. Overall Conclusion: Based on current knowledge, the VKM GMO Panel concludes that maize GA21 is nutritionally equivalent to conventional maize varieties. It is unlikely that the mEPSPS protein will introduce a toxic or allergenic potential in food derived from maize GA21 compared to conventional maize. The VKM GMO Panel likewise concludes that maize GA21, based on current knowledge, is comparable to conventional maize varieties concerning environmental risk in Norway with the intended usage.

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Environment Agency (former Norwegian Directorate for Nature Management) has requested the Norwegian Food Safety Authority (NFSA) to give final opinions on all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC within the Authority’s sectoral responsibility. The Norwegian Food Safety Authority has therefore, by letter dated 13 February 2013 (ref. 2012/150202), requested the Norwegian Scientific Committee for Food Safety (VKM) to carry out scientific risk assessments of 39 GMOs and products containing or consisting of GMOs that are authorized in the European Union. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Agency requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The genetically modified, glufosinate-tolerant oilseed rape lines MS8, RF3 and MS8 x RF3 (Notification C/BE/96/01) are approved under Directive 2001/18/EC for import and processing, for feed and industrial purposes since 26 March 2007 (Commission Decision 2007/232/EC). In addition, processed oil from genetically modified oilseed rape derived from MS8, RF3 and MS8 x RF3 were notified as existing food according to Art. 5 of Regulation (EC) No 258/97 on novel foods and novel food ingredients in November 1999. Existing feed and feed products containing, consisting of or produced from MS8, RF3 and MS8 x RF3 were notified according to Articles 8 and 20 of Regulation (EC) No 1829/2003 and were placed on the market in January 2000. An application for renewal of the authorisation for continued marketing of existing food, food ingredients and feed materials produced from MS8, RF3 and MS8 x RF3 was submitted within the framework of Regulation (EC) No 1829/2003 in June 2007 (EFSA/GMO/RX/MS8/RF3). In addition, an application covering food containing or consisting of, and food produced from or containing ingredients produced from oilseed rape MS8, RF3 and MS8 x RF3 (with the exception of processed oil) was delivered by Bayer CropScience in June 2010 (EFSA/GMO/BE/2010/81). The VKM GMO Panel has previously issued a scientific opinion related to the notification C/BE/96/01 for the placing on the market of the oilseed rape lines for import, processing and feed uses (VKM 2008). The food/feed and environmental risk assessment was commissioned by the Norwegian Environment Agency in connection with the national finalisation of the procedure of the notification C/BE/96/01 in 2008. Due to the publication of updated guidelines for risk assessments of genetically modified plants and new scientific literature, the VKM GMO Panel has decided to deliver an updated food, feed and environmental risk assessment of oilseed rape MS8, RF3 and MS8 x RF3. A scientific opinion on an application for the placing on the market of MS8 x RF3 for food containing or consisting of, and food produced from or containing ingredients produced from MS8 x RF3 (with the exception of processed oil) (EFSA/GMO/BE/2010/81) have also been submitted by the VKM GMO Panel (VKM 2012, unpublished). The risk assessment of the oilseed rape MS8, RF3 and MS8 x RF3 is based on information provided by the notifier in the applications EFSA/GMO/RX/MS8/RF3, EFSA/GMO/BE/2010/81, the notification C/BE/96/01, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MS8, RF3 and MS8 x RF3 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010a) and the selection of comparators for the risk assessment of GM plants (EFSA 2011b). The scientific risk assessment of oilseed rape MS8, RF3 and MS8 x RF3 include molecular characterisation of the inserted DNA and expression of target proteins, comparative compositional assessment, food/feed safety assessment, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness and potential for horizontal and vertical gene transfer. In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. The genetically modified oilseed rape lines MS8 and RF3 were developed to provide a pollination control system for production of F1-hybrid seeds (MS8 x RF3). Oilseed rape is a crop capable of undergoing both self-pollination (70%) as well as cross-pollination (30%). Therefore a system to ensure only cross-pollination is required for producing hybrids from two distinct parents. As a result of hybrid vigor cross-pollinated plants produce higher yield as compared to self-pollinating rape. The hybrid system is achieved using a pollination control system by insertion and expression of barnase and barstar genes derived from the soil bacterium Bacillus amyloliquefaciens into two separate transgenic oilseed rape lines. The barnase gene in the male sterile line MS8 encode a ribonuclease peptide (RNase), expressed in the tapetum cells during anther development. The RNase effect RNA levels, disrupting normal cell function, arresting early anther development, and results in the lack of viable pollen and male sterility. The fertility restoration line RF3 contains a barstar gene, coding for a ribonuclease inhibitor (Barstar peptide) expressed only in the tapetum cells of the pollen during anther development. The peptide specifically inhibits the Barnase RNase expressed by the MS8 line. The RNase and the ribonuclease inhibitor form a stable one-to-one complex, in which the RNase is inactivated. As a result, when pollen from the receptor line RF3 is crossed to the male sterile line MS8, the MS8 x RF3 progeny expresses the RNase inhibitor in the tapetum cells of the anthers allowing hybrid plants to develop normal anthers and restore fertility. The barnase and barstar genes in MS8 and RF3 are each linked with the bar gene from Streptomyces hygroscopus. The bar gene is driven by a plant promoter that is active in all green tissues of the plant, and encodes the enzyme phosphinothricin acetyltransferase (PAT). The PAT enzyme inactivates phosphinothricin (PPT), the active constituent of the non-selective herbicide glufosinate-ammonium. The bar gen were transferred to the oilseed rape plants as markers both for use during in vitro selection and as a breeding selection tool in seed production. Molecular Characterisation: The oilseed rape hybrid MS8 x RF3 is produced by conventional crossing. The parental lines MS8 and RF3 are well described in the documentation provided by the applicant, and a number of publications support their data. It seems likely that MS8 contains a complete copy of the desired T-DNA construct including the bar and barnase genes. Likewise, the event RF3 is likely to contain complete copies of the bar and barstar genes in addition to a second incomplete non-functional copy of the bar-gene. The inserts in the single events are preserved in the hybrid MS8 x RF3, and the desired traits are stably inherited over generations. The GMO Panel finds the characterisation of the physical, chemical and functional properties of the recombinant inserts in the oilseed rape transformation events MS8, RF3 and MS8 x RF3 to be satisfactory. The GMO Panel has not identified any novel risks associated with the modified plants based on the molecular characterisation of the inserts. Comparative Assessment: Based on results from comparative analyses of data from field trials located at representative sites and environments in Europe and Canada, it is concluded that oilseed rape MS8, RF3 and MS8 x RF3 is compositionally, agronomically and phenotypically equivalent to the conventional counterpart, except for the newly expressed barnase, barstar and PAT proteins. In the Canadian field trials, however, compositional and phenotypic characteristics of oilseed rape MS8, RF3 and MS8 x RF3 were compared to null-segregant comparators. As negative segregants are derived from a GM organism, the VKM GMO Panel does not consider them appropriate conventional counterparts with a history of safe use. Data obtained from field trials with negative segregants were considered as supplementary information for the RA. Based on the assessment of available data, the VKM GMO Panel is of the opinion that conventional crossing of oilseed rape MS8 and RF3 to produce the hybrid MS8 x RF3 does not result in interactions that cause compositional, agronomic and phenotypic changes that would raise safety concerns. Food and Feed Risk Assessment: Whole food feeding studies in broilers have not indicated any adverse health effects of oilseed rape MS8 x RF3. These studies also indicate that oilseed rape MS8 x RF3 is nutritionally equivalent to conventional oilseed rape. The PAT protein do not show sequence resemblance to other known toxins or IgE allergens, nor has PAT been reported to cause IgE mediated allergic reactions. Based on the current knowledge, the VKM GMO Panel concludes that oilseed rape MS8 x RF3 is nutritionally equivalent to conventional oilseed rape varieties, and that it is unlikely that the newly expressed proteins introduce a toxic or allergenic potential in food and feed derived from oilseed rape MS8 x RF3 compared to conventional oilseed rape. Environmental Risk Assessment: Considering the scope of the notification C/BE/96/01, excluding cultivation purposes, the environmental risk assessment is limited to exposure through accidental spillage of viable seeds of MS8, RF3 and MS8 x RF3 into the environment during transportation, storage, handling, processing and use of derived products. Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30 %, but outcrossing frequencies up to 55 % are reported. Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas to which gene introgression from oilseed rape could be of concern. These are found both in the Brassica species complex and in related genera. A series of controlled crosses between oilseed rape and related taxa have been reported in the scientific literature. Because of a mismatch in the chromosome numbers most hybrids have a severely reduced fertility. Exceptions are hybrids obtained from crosses between oilseed rape and wild turnip (B. rapa ssp. campestris) and to a lesser extent, mustard greens (B.juncea), where spontaneously hybridising and transgene introgression under field conditions have been confirmed. Wild turnip is native to Norway and a common weed in arable lowlands. Accidental spillage and loss of viable seeds of MS8, RF3 and MS8 x RF3 during transport, storage, handling in the environment and processing into derived products is likely to take place over time, and the establishment of small populations of oilseed rape MS8, RF3 and MS8 x RF3 cannot be excluded. Feral oilseed rape MS8, RF3 and MS8 x RF3 arising from spilled seed could theoretically pollinate conventional crop plants if the escaped populations are immediately adjacent to field crops, and shed seeds from cross-pollinated crop plants could emerge as GM volunteers in subsequent crops. However, both the occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario in Norway. There is no evidence that the herbicide tolerant trait results in enhanced fitness, persistence or invasiveness of oilseed rape MS8, RF3 and MS8 x RF3, or hybridizing wild relatives, compared to conventional oilseed rape varieties, unless the plants are exposed to herbicides with the active substance glufosinate ammonium. Apart from the glufosinate tolerance trait, the resulting progeny will not possess a higher fitness and will not be different from progeny arising from cross-fertilisation with conventional oilseed rape varieties. Glufosinate ammonium-containing herbicides have been withdrawn from the Norwegian market since 2008, and the substance will be phased out in the EU in 2017 for reasons of reproductive toxicity. Overall Conclusion: Based on current knowledge, the VKM GMO Panel has not identified toxic, allergenic or altered nutritional properties of oilseed rape MS8, RF3 and MS8 x RF3 or its processed products compared to conventional oilseed rape. The VKM GMO Panel likewise concludes that oilseed rape MS8, RF3 and MS8 x RF3 are unlikely to have any adverse effect on the environment and agriculture in Norway in the context of its intended usage.

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Directorate for Nature Management to conduct final environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Directorate requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. The genetically modified, glufosinate-tolerant oilseed rape lines MS8, RF3 and MS8 x RF3 (Notification C/BE/96/01) are approved under Directive 2001/18/EC for import and processing for feed and industrial purposes since 26 March 2007 (Commission Decision 2007/232/EC). In addition, processed oil from genetically modified oilseed rape derived from MS8, RF3 and MS8 x RF3 were notified as existing food according to Art. 5 of Regulation (EC) No 258/97 on novel foods and novel food ingredients in November 1999. Existing feed and feed products containing, consisting of or produced from MS8, RF3 and MS8 x RF3 were notified according to Articles 8 and 20 of Regulation (EC) No 1829/2003 and were placed on the market in January 2000. An application for renewal of the authorisation for continued marketing of existing food, food ingredients and feed materials produced from MS8, RF3 and MS8 x RF3 was submitted within the framework of Regulation (EC) No 1829/2003 in June 2007 (EFSA/GMO/RX/MS8/RF3). In addition, an application covering food containing or consisting of, and food produced from or containing ingredients produced from oilseed rape MS8, RF3 and MS8 x RF3 (with the exception of processed oil) was delivered by Bayer CropScience in June 2010 (EFSA/GMO/BE/2010/81). The VKM GMO Panel has previously issued a scientific opinion related to the notification C/BE/96/01 for the placing on the market of the oilseed rape lines for import, processing and feed uses (VKM 2008). The health and environmental risk assessment was commissioned by the Norwegian Directorate for Nature Management in connection with the national finalisation of the procedure of the notification C/BE/96/01 in 2008. Due to the publication of updated guidelines for environmental risk assessments of genetically modified plants and new scientific literature, the VKM GMO Panel has decided to deliver an updated environmental risk assessment of oilseed rape MS8, RF3 and MS8 x RF3. A scientific opinion on an application for the placing on the market of MS8/RF3 for food containing or consisting of, and food produced from or containing ingredients produced from MS8/RF3 (with the exception of processed oil) (EFSA/GMO/BE/2010/81) have also been submitted by the VKM GMO Panel (VKM 2012). The environmental risk assessment of the oilseed rape MS8, RF3 and MS8 x RF3 is based on information provided by the notifier in the applications EFSA/GMO/RX/MS8/RF3, EFSA/GMO/BE/2010/8, the notification C/BE/96/01, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MS8, RF3 and MS8 x RF3 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c). The scientific risk assessment of oilseed rape MS8, RF3 and MS8 x RF3 include molecular characterisation of the inserted DNA and expression of target proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for horizontal and vertical gene transfer, and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. The genetically modified oilseed rape lines MS8 and RF3 were developed to provide a pollination control system for production of F1-hybrid seeds (MS8 x RF3). Oilseed rape is a crop capable of undergoing both self-pollination (70%) as well as cross-pollination (30%). Therefore a system to ensure only cross-pollination is required for producing hybrids from two distinct parents. As a result of hybrid vigor cross-pollinated plants produce higher yield as compared to self-pollinating rape. The hybrid system is achieved using a pollination control system by insertion and expression of barnase and barstar genes derived from the soil bacterium Bacillus amyloliquefaciens into two separate transgenic oilseed rape lines. The barnase gene in the male sterile line MS8 encode a ribonuclease peptide (RNase), expressed in the tapetum cells during anther development. The RNase effect RNA levels, disrupting normal cell function, arresting early anther development, and results in the lack of viable pollen and male sterility. The fertility restoration line RF3 contains a barstar gene, coding for a ribonuclease inhibitor (Barstar peptide) expressed only in the tapetum cells of the pollen during anther development. The peptide specifically inhibits the Barnase RNase expressed by the MS8 line. The RNase and the ribonuclease inhibitor form a stable one-to-one complex, in which the RNase is inactivated. As a result, when pollen from the receptor line RF3 is crossed to the male sterile line MS8, the MS8 x RF3 progeny expresses the RNase inhibitor in the tapetum cells of the anthers allowing hybrid plants to develop normal anthers and restore fertility. The barnase and barstar genes in MS8 and RF3 are each linked with the bar gene from Streptomyces hygroscopus. The bar gene is driven by a plant promoter that is active in all green tissues of the plant, and encodes the enzyme phosphinothricin acetyltransferase (PAT). The PAT enzyme inactivates phosphinothricin (PPT), the active constituent of the non-selective herbicide glufosinate-ammonium. The bar gen were transferred to the oilseed rape plants as markers both for use during in vitro selection and as a breeding selection tool in seed production. Molecular characterization: The oilseed rape hybrid MS8xRF3 is produced by conventional crossing. The parental lines MS8 and RF3 are well described in the documentation provided by the applicant, and a number of publications support their data. It seems likely that MS8 contains a complete copy of the desired T-DNA construct including the bar and barnase genes. Likewise, the event RF3 is likely to contain complete copies of the bar and barstar genes in addition to a second incomplete non-functional copy of the bar-gene. The inserts in the single events are preserved in the hybrid MS8xRF3, and the desired traits are stably inherited over generations. Oilseed rape MS8, RF3 and MS8xRF3 and the physical, chemical and functional characteristics of the newly expressed proteins have previously been evaluated by the VKM Panel on Genetically Modified Organisms, and considered satisfactory (VKM 2008, 2012). The GMO Panel finds the characterisation of the physical, chemical and functional properties of the recombinant inserts in the oilseed rape transformation events MS8, RF3 and MS8xRF3 to be satisfactory. The GMO Panel has not identified any novel risks associated with the modified plants based on the molecular characterisation of the inserts. Comparative assessment: Based on results from comparative analyses of data from field trials located at representative sites and environments in Europe and Canada, it is concluded that oilseed rape MS8, RF3 and MS8 x RF3 is agronomically and phenotypically equivalent to the conventional counterpart, except for the newly expressed barnase, barstar and PAT proteins. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of event MS8, RF3 and MS8 x RF3 compared to conventional oilseed rape. Furthermore, the results demonstrate that in-crop applications of glufosinate herbicide do not alter the phenotypic and agronomic characteristics of event MS8, RF3 and MS8 x RF3 compared to conventional oilseed rape varieties. Environmental risk: Considering the scope of the notification C/BE/96/01, excluding cultivation purposes, the environmental risk assessment is limited to exposure through accidental spillage of viable seeds of MS8, RF3 and MS8 x RF3 into the environment during transportation, storage, handling, processing and use of derived products. Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30%, but outcrossing frequencies up to 55% are reported. Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas to which gene introgression from oilseed rape could be of concern. These are found both in the Brassica species complex and in related genera. A series of controlled crosses between oilseed rape and related taxa have been reported in the scientific literature. Because of a mismatch in the chromosome numbers most hybrids have a severely reduced fertility. Exceptions are hybrids obtained from crosses between oilseed rape and wild turnip (B. rapa ssp. campestris) and to a lesser extent, mustard greens (B. juncea), where spontaneously hybridising and transgene introgression under field conditions have been confirmed. Wild turnip is native to Norway and a common weed in arable lowlands. Accidental spillage and loss of viable seeds of MS8, RF3 and MS8 x RF3 during transport, storage, handling in the environment and processing into derived products is likely to take place over time, and the establishment of small populations of oilseed rape MS8, RF3 and MS8 x RF3 cannot be excluded. Feral oilseed rape MS8, RF3 and MS8 x RF3 arising from spilled seed could theoretically pollinate conventional crop plants if the escaped populations are immediately adjacent to field crops, and shed seeds from cross-pollinated crop plants could emerge as GM volunteers in subsequent crops. However, both the occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario in Norway. There is no evidence that the herbicide tolerant trait results in enhanced fitness, persistence or invasiveness of oilseed rape MS8, RF3 and MS8 x RF3, or hybridizing wild relatives, compared to conventional oilseed rape varieties, unless the plants are exposed to herbicides with the active substance glufosinate ammonium. Apart from the glufosinate tolerance trait, the resulting progeny will not possess a higher fitness and will not be different from progeny arising from cross-fertilisation with conventional oilseed rape varieties. Glufosinate ammonium-containing herbicides have been withdrawn from the Norwegian market since 2008, and the substance will be phased out in the EU in 2017 for reasons of reproductive toxicity. Overall conclusion: The VKM GMO Panel concludes that oilseed rape MS8, RF3 and MS8xRF3 are unlikely to have any adverse effect on the environment in Norway in the context of its intended usage.

In preparation for a legal implementation of EU-regulation 1829/2003, the Norwegian Scientific Committee for Food Safety (VKM) has been requested by the Norwegian Directorate for Nature Management to conduct final environmental risk assessments for all genetically modified organisms (GMOs) and products containing or consisting of GMOs that are authorized in the European Union under Directive 2001/18/EC or Regulation 1829/2003/EC. The request covers scope(s) relevant to the Gene Technology Act. The request does not cover GMOs that VKM already has conducted its final risk assessments on. However, the Directorate requests VKM to consider whether updates or other changes to earlier submitted assessments are necessary. MON810 notification C/F/95/12-02 is approved under Directive 90/220/EEC for cultivation, seed production, import and processing into feeding stuffs and industrial purposes since 22 April 1998 (Commission Decision 98/294/EC). In December 1997, food and food ingredients derived from the progeny of maize line MON810 were notified under Article 5 of Regulation (EC) No 258/97 on novel foods and novel food ingredients. In addition, existing food and feed products containing, consisting of or produced from MON810 were notified according to Articles 8 and 20 of Regulation (EC) No 1829/2003 and were placed in the Community Register in 2005. Three applications for renewal of the authorisation for continued marketing of (1) existing food and food ingredients produced from MON810; (2) feed consisting of and/or containing maize MON810, and MON810 for feed use (including cultivation); and (3) food and feed additives, and feed materials produced from maize MON810 within the framework of Regulation (EC) No 1829/2003 were submitted in 2007. Maize MON810 has previously been assessed by the VKM GMO Panel commissioned by the Norwegian Directorate for Nature Management in connection with the national finalisation of the procedure of the notification C/F/95/12/02 (VKM 2007a,b). In addition, MON810 has been evaluated by the VKM GMO Panel as a component of several stacked GM maize events (VKM 2005a,b,c, VKM 2007c, VKM 2008, VKM 2009, VKM 2012). Due to the publication of updated guidelines for environmental risk assessments of genetically modified plants and new scientific literature, the VKM GMO Panel has decided to deliver an updated environmental risk assessment of MON810. The environmental risk assessment of the maize MON810 is based on information provided by the applicant in the notification C/F/95/12/02 and application EFSA/GMO/RX/MON810, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered other peer-reviewed scientific literature as relevant. The VKM GMO Panel has evaluated MON810 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c). The scientific risk assessment of maize MON810 include molecular characterisation of the inserted DNA and expression of the target protein, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms, effects on biogeochemical processes and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. The genetically modified maize MON810 was developed to provide protection against certain lepidopteran target pests, including European corn borer (Ostrinia nubilalis) and species belonging to the genus Sesamia. Protection is achieved through expression in the plant of the insecticidal Cry protein, Cry1Ab, derived from Bacillus thuringiensis ssp. kurstaki, a common soil bacterium. Molecular characterisation Appropriate analysis of the integration site including flanking sequences and bioinformatics analyses have been performed to analyse the construct integrated in the GM plant. Updated bioinformatics analyses revealed that one ORF shared sequence similarity to a putative HECT-ubiquitin ligase protein. The VKM GMO Panel found no safety implications from the interruption of this gene sequence. Analyses of leaf, grains, whole plant tissue and pollen from the maize MON 810 demonstrated that the Cry1Ab protein is expressed at very low levels in all tissues tested and constitutes less than 0.001% of the fresh weight in each tissue. The cry1Ab gene is the only transgene expressed in line MON 810 and was expressed highest in the leaves. The stability of the genetic modification has been demonstrated over several generations. Event MON810 and the physical, chemical and functional characteristics of the proteins have previously been evaluated by The VKM Panel on Genetically Modified Organisms, and considered satisfactory (VKM 2007a,b). Comparative assessment: Comparative analyses of data from field trials located at representative sites and environments in the USA and Europe indicate that maize MON810 is agronomically and phenotypically equivalent to the conventional counterpart and commercially available reference varieties, with the exception of the lepidopteran-protection trait, conferred by the expression of the Cry1Ab protein. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of MON810 compared to conventional maize. Evaluations of ecological interactions between maize MON810 and the biotic and abiotic environment indicate no unintended effects of the introduced trait on agronomic and phenotypic characteristics. Environmental risk: There are no reports of the target lepidopteran species attaining pest status on maize in Norway. Since there are no Bt-based insecticides approved for use in Norway, and lepidopteran pests have not been registered in maize, issues related to resistance evolution in target pests are not relevant at present for Norwegian agriculture. Published scientific studies show no or negligible adverse effects of Cry1Ab protein on non-target arthropods that live on or in the vicinity of maize plants. Cultivation of maize MON810 is not considered to represent a threat to the prevalence of red-listed species in Norway. Few studies have been published examining potential effects of Cry1Ab toxin on ecosystems in soil, mineralization, nutrient turnover and soil communities. Some field studies have indicated that root exudates and decaying plant material containing Cry proteins may affect population size and activity of rhizosphere organisms (soil protozoa and microorganisms). Most studies conclude that effects on soil microorganisms and microbial communities are transient and minor compared to effects caused by agronomic and environmental factors. However, data are only available from short term experiments and predictions of potential long term effects are difficult to deduce. Few studies have assessed the impact of Cry proteins on non-target aquatic arthropods and the fate of these proteins in senescent and decaying maize detritus in aquatic environments. However, exposure of non-target organisms to Cry proteins in aquatic ecosystems is likely to be very low, and potential exposure of Bt toxins to non-target organisms in aquatic ecosystems in Norway is considered to be negligible. Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation with which maize can hybridise and form backcross progeny. Vertical gene transfer in maize therefore depends on cross-pollination with other conventional or organic maize varieties. In addition, unintended admixture of genetically modified material in seeds represents a possible way for gene flow between different crop cultivations. The risk of pollen flow from maize volunteers is negligible under Norwegian growing conditions. In addition to the data presented by the applicant, the VKM GMO Panel is not aware of any scientific report of increased establishment and spread of maize MON810 and any change in survival (including over-wintering), persistence and invasiveness capacity. Because the general characteristics of maize MON810 are unchanged, insect resistance are not likely to provide a selective advantage outside cultivation in Norway. Since MON810 has no altered agronomic and phenotypic characteristics, except for the specific target pest resistance, the VKM GMO Panel is of the opinion that the likelihood of unintended environmental effects due to the establishment and survival of maize MON810 will be no different to that of conventional maize varieties in Norway. Overall conclusion: The VKM GMO Panel concludes that cultivation of maize MON810 is unlikely to have any adverse effect on the environment in Norway.

IntroductionRegional identity is a constant construction, in which landscape, human activity and cultural imaginary build a narrative of place. For the Tasmanian Midlands, the interactions between history, ecology and agriculture both define place and present problems in how to recognise, communicate and balance these interactions. In this sense, regionality is defined not so much as a relation of margin to centre, but as a specific accretion of environmental and cultural histories. According weight to more-than-human perspectives, a region can be seen as a constellation of plant, animal and human interactions and demands, where creative art and design can make space and give voice to the dynamics of exchange between the landscape and its inhabitants. Consideration of three recent art and design projects based in the Midlands reveal the potential for cross-disciplinary research, embedded in both environment and community, to create distinctive and specific forms of connectivity that articulate a regional identify.The Tasmanian Midlands have been identified as a biodiversity hotspot (Australian Government), with a long history of Aboriginal cultural management disrupted by colonial invasion. Recent archaeological work in the Midlands, including the Kerry Lodge Archaeology and Art Project, has focused on the use of convict labour during the nineteenth century in opening up the Midlands for settler agriculture and transport. Now, the Midlands are placed under increasing pressure by changing agricultural practices such as large-scale irrigation. At the same time as this intensification of agricultural activity, significant progress has been made in protecting, preserving and restoring endemic ecologies. This progress has come through non-government conservation organisations, especially Greening Australia and their program Tasmanian Island Ark, and private landowners placing land under conservation covenants. These pressures and conservation activities give rise to research opportunities in the biological sciences, but also pose challenges in communicating the value of conservation and research outcomes to a wider public. The Species Hotel project, beginning in 2016, engaged with the aims of restoration ecology through speculative design while The Marathon Project, a multi-year curatorial art project based on a single property that contains both conservation and commercially farmed zones.This article questions the role of regionality in these three interconnected projects—Kerry Lodge, Species Hotel, and Marathon—sited in the Tasmanian Midlands: the three projects share a concern with the specificities of the region through engagement with specifics sites and their histories and ecologies, while also acknowledging the forces that shape these sites as far more mobile and global in scope. It also considers the interdisciplinary nature of these projects, in the crossover of art and design with ecological, archaeological and agricultural practices of measuring and intervening in the land, where communication and interpretation may be in tension with functionality. These projects suggest ways of working that connect the ecological and the cultural spheres; importantly, they see rural locations as sites of knowledge production; they test the value of small-scale and ephemeral interventions to explore the place of art and design as intervention within colonised landscape.Regions are also defined by overlapping circles of control, interest, and authority. We test the claim that these projects, which operate through cross-disciplinary collaboration and network with a range of stakeholders and community groups, successfully benefit the region in which they are placed. We are particularly interested in the challenges of working across institutions which both claim and enact connections to the region without being centred there. These projects are initiatives resulting from, or in collaboration with, University of Tasmania, an institution that has taken a recent turn towards explicitly identifying as place-based yet the placement of the Midlands as the gap between campuses risks attenuating the institution’s claim to be of this place. Paul Carter, in his discussion of a regional, site-specific collaboration in Alice Springs, flags how processes of creative place-making—operating through mythopoetic and story-based strategies—requires a concrete rather than imagined community that actively engages a plurality of voices on the ground. We identify similar concerns in these art and design projects and argue that iterative and long-term creative projects enable a deeper grappling with the complexities of shared regional place-making. The Midlands is aptly named: as a region, it is defined by its geographical constraints and relationships to urban centres. Heading south from the northern city of Launceston, travellers on the Midland Highway see scores of farming properties networking continuously for around 175 kilometres south to the outskirts of Brighton, the last major township before the Tasmanian capital city of Hobart. The town of Ross straddles latitude 42 degrees south—a line that has historically divided Tasmania into the divisions of North and South. The region is characterised by extensive agricultural usage and small remnant patches of relatively open dry sclerophyll forest and lowland grassland enabled by its lower attitude and relatively flatter terrain. The Midlands sit between the mountainous central highlands of the Great Western Tiers and the Eastern Tiers, a continuous range of dolerite hills lying south of Ben Lomond that slope coastward to the Tasman Sea. This area stretches far beyond the view of the main highway, reaching east in the Deddington and Fingal valleys. Campbell Town is the primary stopping point for travellers, superseding the bypassed towns, which have faced problems with lowering population and resulting loss of facilities.Image 1: Southern Midland Landscape, Ross, Tasmania, 2018. Image Credit: Patrick Sutczak.Predominantly under private ownership, the Tasmanian Midlands are a contested and fractured landscape existing in a state of ecological tension that has occurred with the dominance of western agriculture. For over 200 years, farmers have continually shaped the land and carved it up into small fragments for different agricultural agendas, and this has resulted in significant endemic species decline (Mitchell et al.). The open vegetation was the product of cultural management of land by Tasmanian Aboriginal communities (Gammage), attractive to settlers during their distribution of land grants prior to the 1830s and a focus for settler violence. As documented cartographically in the Centre for 21st Century Humanities’ Colonial Frontier Massacres in Central and Eastern Australia 1788–1930, the period 1820–1835, and particularly during the Black War, saw the Midlands as central to the violent dispossession of Aboriginal landowners. Clements argues that the culture of violence during this period also reflected the brutalisation that the penal system imposed upon its subjects. The cultivation of agricultural land throughout the Midlands was enabled by the provision of unfree convict labour (Dillon). Many of the properties granted and established during the colonial period have been held in multi-generational family ownership through to the present.Within this patchwork of private ownership, the tension between visibility and privacy of the Midlands pastures and farmlands challenges the capacity for people to understand what role the Midlands plays in the greater Tasmanian ecology. Although half of Tasmania’s land areas are protected as national parks and reserves, the Midlands remains largely unprotected due to private ownership. When measured against Tasmania’s wilderness values and reputation, the dry pasturelands of the Midland region fail to capture an equivalent level of visual and experiential imagination. Jamie Kirkpatrick describes misconceptions of the Midlands when he writes of “[f]latness, dead and dying eucalypts, gorse, brown pastures, salt—environmental devastation […]—these are the common impression of those who first travel between Spring Hill and Launceston on the Midland Highway” (45). However, Kirkpatrick also emphasises the unique intimate and intricate qualities of this landscape, and its underlying resilience. In the face of the loss of paddock trees and remnants to irrigation, change in species due to pasture enrichment and introduction of new plant species, conservation initiatives that not only protect but also restore habitat are vital. The Tasmanian Midlands, then, are pastoral landscapes whose seeming monotonous continuity glosses over the radical changes experienced in the processes of colonisation and intensification of agriculture.Underlying the Present: Archaeology and Landscape in the Kerry Lodge ProjectThe major marker of the Midlands is the highway that bisects it. Running from Hobart to Launceston, the construction of a “great macadamised highway” (Department of Main Roads 10) between 1820–1850, and its ongoing maintenance, was a significant colonial project. The macadam technique, a nineteenth century innovation in road building which involved the laying of small pieces of stone to create a surface that was relatively water and frost resistant, required considerable but unskilled labour. The construction of the bridge at Kerry Lodge, in 1834–35, was simultaneous with significant bridge buildings at other major water crossings on the highway, (Department of Main Roads 16) and, as the first water crossing south of Launceston, was a pinch-point through which travel of prisoners could be monitored and controlled. Following the completion of the bridge, the site was used to house up to 60 male convicts in a road gang undergoing secondary punishment (1835–44) and then in a labour camp and hiring depot until 1847. At the time of the La Trobe report (1847), the buildings were noted as being in bad condition (Brand 142–43). After the station was disbanded, the use of the buildings reverted to the landowners for use in accommodation and agricultural storage.Archaeological research at Kerry Lodge, directed by Eleanor Casella, investigated the spatial and disciplinary structures of smaller probation and hiring depots and the living and working conditions of supervisory staff. Across three seasons (2015, 2016, 2018), the emerging themes of discipline and control and as well as labour were borne out by excavations across the site, focusing on remnants of buildings close to the bridge. This first season also piloted the co-presence of a curatorial art project, which grew across the season to include eleven practitioners in visual art, theatre and poetry, and three exhibition outcomes. As a crucial process for the curatorial art project, creative practitioners spent time on site as participants and observers, which enabled the development of responses that interrogated the research processes of archaeological fieldwork as well as making connections to the wider historical and cultural context of the site. Immersed in the mundane tasks of archaeological fieldwork, the practitioners involved became simultaneously focused on repetitive actions while contemplating the deep time contained within earth. This experience then informed the development of creative works interrogating embodied processes as a language of site.The outcome from the first fieldwork season was earthspoke, an exhibition shown at Sawtooth, an artist-run initiative in Launceston in 2015, and later re-installed in Franklin House, a National Trust property in the southern suburbs of Launceston.Images 2 and 3: earthspoke, 2015, Installation View at Sawtooth ARI (top) and Franklin House (bottom). Image Credits: Melanie de Ruyter.This recontextualisation of the work, from contemporary ARI (artist run initiative) gallery to National Trust property enabled the project to reach different audiences but also raised questions about the emphases that these exhibition contexts placed on the work. Within the white cube space of the contemporary gallery, connections to site became more abstracted while the educational and heritage functions of the National Trust property added further context and unintended connotations to the art works.Image 4: Strata, 2017, Installation View. Image Credit: Karen Hall.The two subsequent exhibitions, Lines of Site (2016) and Strata (2017), continued to test the relationship between site and gallery, through works that rematerialised the absences on site and connected embodied experiences of convict and archaeological labour. The most recent iteration of the project, Strata, part of the Ten Days on the Island art festival in 2017, involved installing works at the site, marking with their presence the traces, fragments and voids that had been reburied when the landscape returned to agricultural use following the excavations. Here, the interpretive function of the works directly addressed the layered histories of the landscape and underscored the scope of the human interventions and changes over time within the pastoral landscape. The interpretative role of the artworks formed part of a wider, multidisciplinary approach to research and communication within the project. University of Manchester archaeology staff and postgraduate students directed the excavations, using volunteers from the Launceston Historical Society. Staff from Launceston’s Queen Victorian Museum and Art Gallery brought their archival and collection-based expertise to the site rather than simply receiving stored finds as a repository, supporting immediate interpretation and contextualisation of objects. In 2018, participation from the University of Tasmania School of Education enabled a larger number of on-site educational activities than afforded by previous open days. These multi-disciplinary and multi-organisational networks, drawn together provisionally in a shared time and place, provided rich opportunities for dialogue. However, the challenges of sustaining these exchanges have meant ongoing collaborations have become more sporadic, reflecting different institutional priorities and competing demands on participants. Even within long-term projects, continued engagement with stakeholders can be a challenge: while enabling an emerging and concrete sense of community, the time span gives greater vulnerability to external pressures. Making Home: Ecological Restoration and Community Engagement in the Species Hotel ProjectImages 5 and 6: Selected Species Hotels, Ross, Tasmania, 2018. Image Credits: Patrick Sutczak. The Species Hotels stand sentinel over a river of saplings, providing shelter for animal communities within close range of a small town. At the township of Ross in the Southern Midlands, work was initiated by restoration ecologists to address the lack of substantial animal shelter belts on a number of major properties in the area. The Tasmania Island Ark is a major Greening Australia restoration ecology initiative, connecting 6000 hectares of habitat across the Midlands. Linking larger forest areas in the Eastern Tiers and Central Highlands as well as isolated patches of remnant native vegetation, the Ark project is vital to the ongoing survival of local plant and animal species under pressure from human interventions and climate change. With fragmentation of bush and native grasslands in the Midland landscape resulting in vast open plains, the ability for animals to adapt to pasturelands without shelter has resulted in significant decline as animals such as the critically endangered Eastern Barred Bandicoot struggle to feed, move, and avoid predators (Cranney). In 2014 mass plantings of native vegetation were undertaken along 16km of the serpentine Macquarie River as part of two habitat corridors designed to bring connectivity back to the region. While the plantings were being established a public art project was conceived that would merge design with practical application to assist animals in the area, and draw community and public attention to the work that was being done in re-establishing native forests. The Species Hotel project, which began in 2016, emerged from a collaboration between Greening Australia and the University of Tasmania’s School of Architecture and Design, the School of Land and Food, the Tasmanian College of the Arts and the ARC Centre for Forest Value, with funding from the Ian Potter Foundation. The initial focus of the project was the development of interventions in the landscape that could address the specific habitat needs of the insect, small mammal, and bird species that are under threat. First-year Architecture students were invited to design a series of structures with the brief that they would act as ‘Species Hotels’, and once created would be installed among the plantings as structures that could be inhabited or act as protection. After installation, the privately-owned land would be reconfigured so to allow public access and observation of the hotels, by residents and visitors alike. Early in the project’s development, a concern was raised during a Ross community communication and consultation event that the surrounding landscape and its vistas would be dramatically altered with the re-introduced forest. While momentary and resolved, a subtle yet obvious tension surfaced that questioned the re-writing of an established community’s visual landscape literacy by non-residents. Compact and picturesque, the architectural, historical and cultural qualities of Ross and its location were not only admired by residents, but established a regional identity. During the six-week intensive project, the community reach was expanded beyond the institution and involved over 100 people including landowners, artists, scientists and school children from the region (Wright), attempting to address and channel the concerns of residents about the changing landscape. The multiple timescales of this iterative project—from intensive moments of collaboration between stakeholders to the more-than-human time of tree growth—open spaces for regional identity to shift as both as place and community. Part of the design brief was the use of fully biodegradable materials: the Species Hotels are not expected to last forever. The actual installation of the Species Hotelson site took longer than planned due to weather conditions, but once on site they were weathering in, showing signs of insect and bird habitation. This animal activity created an opportunity for ongoing engagement. Further activities generated from the initial iteration of Species Hotel were the Species Hotel Day in 2017, held at the Ross Community Hall where presentations by scientists and designers provided feedback to the local community and presented opportunities for further design engagement in the production of ephemeral ‘species seed pies’ placed out in and around Ross. Architecture and Design students have gone on to develop more examples of ‘ecological furniture’ with a current focus on insect housing as well as extrapolating from the installation of the Species Hotels to generate a VR visualisation of the surrounding landscape, game design and participatory movement work that was presented as part of the Junction Arts Festival program in Launceston, 2017. The intersections of technologies and activities amplified the lived in and living qualities of the Species Hotels, not only adding to the connectivity of social and environmental actions on site and beyond, but also making a statement about the shared ownership this project enabled.Working Property: Collaboration and Dialogues in The Marathon Project The potential of iterative projects that engage with environmental concerns amid questions of access, stewardship and dialogue is also demonstrated in The Marathon Project, a collaborative art project that took place between 2015 and 2017. Situated in the Northern Midland region of Deddington alongside the banks of the Nile River the property of Marathon became the focal point for a small group of artists, ecologists and theorists to converge and engage with a pastoral landscape over time that was unfamiliar to many of them. Through a series of weekend camps and day trips, the participants were able to explore and follow their own creative and investigative agendas. The project was conceived by the landowners who share a passion for the history of the area, their land, and ideas of custodianship and ecological responsibility. The intentions of the project initially were to inspire creative work alongside access, engagement and dialogue about land, agriculture and Deddington itself. As a very small town on the Northern Midland fringe, Deddington is located toward the Eastern Tiers at the foothills of the Ben Lomond mountain ranges. Historically, Deddington is best known as the location of renowned 19th century landscape painter John Glover’s residence, Patterdale. After Glover’s death in 1849, the property steadily fell into disrepair and a recent private restoration effort of the home, studio and grounds has seen renewed interest in the cultural significance of the region. With that in mind, and with Marathon a neighbouring property, participants in the project were able to experience the area and research its past and present as a part of a network of working properties, but also encouraging conversation around the region as a contested and documented place of settlement and subsequent violence toward the Aboriginal people. Marathon is a working property, yet also a vital and fragile ecosystem. Marathon consists of 1430 hectares, of which around 300 lowland hectares are currently used for sheep grazing. The paddocks retain their productivity, function and potential to return to native grassland, while thickets of gorse are plentiful, an example of an invasive species difficult to control. The rest of the property comprises eucalypt woodlands and native grasslands that have been protected under a conservation covenant by the landowners since 2003. The Marathon creek and the Nile River mark the boundary between the functional paddocks and the uncultivated hills and are actively managed in the interface between native and introduced species of flora and fauna. This covenant aimed to preserve these landscapes, linking in with a wider pattern of organisations and landowners attempting to address significant ecological degradation and isolation of remnant bushland patches through restoration ecology. Measured against the visibility of Tasmania’s wilderness identity on the national and global stage, many of the ecological concerns affecting the Midlands go largely unnoticed. The Marathon Project was as much a project about visibility and communication as it was about art and landscape. Over the three years and with its 17 participants, The Marathon Project yielded three major exhibitions along with numerous public presentations and research outputs. The length of the project and the autonomy and perspectives of its participants allowed for connections to be formed, conversations initiated, and greater exposure to the productivity and sustainability complexities playing out on rural Midland properties. Like Kerry Lodge, the 2015 first year exhibition took place at Sawtooth ARI. The exhibition was a testing ground for artists, and a platform for audiences, to witness the cross-disciplinary outputs of work inspired by a single sheep grazing farm. The interest generated led to the rethinking of the 2016 exhibition and the need to broaden the scope of what the landowners and participants were trying to achieve. Image 7: Panel Discussion at Open Weekend, 2016. Image Credit: Ron Malor.In November 2016, The Marathon Project hosted an Open Weekend on the property encouraging audiences to visit, meet the artists, the landowners, and other invited guests from a number of restoration, conservation, and rehabilitation organisations. Titled Encounter, the event and accompanying exhibition displayed in the shearing shed, provided an opportunity for a rhizomatic effect with the public which was designed to inform and disseminate historical and contemporary perspectives of land and agriculture, access, ownership, visitation and interpretation. Concluding with a final exhibition in 2017 at the University of Tasmania’s Academy Gallery, The Marathon Project had built enough momentum to shape and inform the practice of its participants, the knowledge and imagination of the public who engaged with it, and make visible the precarity of the cultural and rural Midland identity.Image 8. Installation View of The Marathon Project Exhibition, 2017. Image Credit: Patrick Sutczak.ConclusionThe Marathon Project, Species Hotel and the Kerry Lodge Archaeology and Art Project all demonstrate the potential of site-based projects to articulate and address concerns that arise from the environmental and cultural conditions and histories of a region. Beyond the Midland fence line is a complex environment that needed to be experienced to be understood. Returning creative work to site, and opening up these intensified experiences of place to a public forms a key stage in all these projects. Beyond a commitment to site-specific practice and valuing the affective and didactic potential of on-site installation, these returns grapple with issues of access, visibility and absence that characterise the Midlands. Paul Carter describes his role in the convening of a “concretely self-realising creative community” in an initiative to construct a meeting-place in Alice Springs, a community defined and united in “its capacity to imagine change as a negotiation between past, present and future” (17). Within that regional context, storytelling, as an encounter between histories and cultures, became crucial in assembling a community that could in turn materialise story into place. In these Midlands projects, a looser assembly of participants with shared interests seek to engage with the intersections of plant, human and animal activities that constitute and negotiate the changing environment. The projects enabled moments of connection, of access, and of intervention: always informed by the complexities of belonging within regional locations.These projects also suggest the need to recognise the granularity of regionalism: the need to be attentive to the relations of site to bioregion, of private land to small town to regional centre. The numerous partnerships that allow such interconnect projects to flourish can be seen as a strength of regional areas, where proximity and scale can draw together sets of related institutions, organisations and individuals. However, the tensions and gaps within these projects reveal differing priorities, senses of ownership and even regional belonging. Questions of who will live with these project outcomes, who will access them, and on what terms, reveal inequalities of power. Negotiations of this uneven and uneasy terrain require a more nuanced account of projects that do not rely on the geographical labelling of regions to paper over the complexities and fractures within the social environment.These projects also share a commitment to the intersection of the social and natural environment. They recognise the inextricable entanglement of human and more than human agencies in shaping the landscape, and material consequences of colonialism and agricultural intensification. Through iteration and duration, the projects mobilise processes that are responsive and reflective while being anchored to the materiality of site. Warwick Mules suggests that “regions are a mixture of data and earth, historically made through the accumulation and condensation of material and informational configurations”. Cross-disciplinary exchanges enable all three projects to actively participate in data production, not interpretation or illustration afterwards. Mules’ call for ‘accumulation’ and ‘configuration’ as productive regional modes speaks directly to the practice-led methodologies employed by these projects. The Kerry Lodge and Marathon projects collect, arrange and transform material taken from each site to provisionally construct a regional material language, extended further in the dual presentation of the projects as off-site exhibitions and as interventions returning to site. The Species Hotel project shares that dual identity, where materials are chosen for their ability over time, habitation and decay to become incorporated into the site yet, through other iterations of the project, become digital presences that nonetheless invite an embodied engagement.These projects centre the Midlands as fertile ground for the production of knowledge and experiences that are distinctive and place-based, arising from the unique qualities of this place, its history and its ongoing challenges. Art and design practice enables connectivity to plant, animal and human communities, utilising cross-disciplinary collaborations to bring together further accumulations of the region’s intertwined cultural and ecological landscape.ReferencesAustralian Government Department of the Environment and Energy. Biodiversity Conservation. Canberra: Commonwealth of Australia, 2018. 1 Apr. 2019 <http://www.environment.gov.au/biodiversity/conservation>.Brand, Ian. The Convict Probation System: Van Diemen’s Land 1839–1854. Sandy Bay: Blubber Head Press, 1990.Carter, Paul. “Common Patterns: Narratives of ‘Mere Coincidence’ and the Production of Regions.” Creative Communities: Regional Inclusion & the Arts. Eds. Janet McDonald and Robert Mason. Bristol: Intellect, 2015. 13–30.Centre for 21st Century Humanities. Colonial Frontier Massacres in Central and Eastern Australia 1788–1930. 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